On June 4, 2020 Hutchison China MediTech Limited ("Chi-Med") (Nasdaq/AIM: HCM) reported that the Independent Data Monitoring Committee (IDMC) of the FRUTIGA study of fruquintinib has completed a planned interim data review (Press release, Hutchison China MediTech, JUN 4, 2020, https://www.chi-med.com/chi-med-announces-the-continuation-of-phase-iii-frutiga-study/ [SID1234560818]). Based on the preset criteria, the IDMC recommended that the trial continue.

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FRUTIGA is a Phase III trial in China of fruquintinib in combination with paclitaxel (Taxol) in the treatment of patients with advanced gastric adenocarcinoma or gastroesophageal junction ("GEJ") adenocarcinoma who have progressed after first-line standard chemotherapy.

About Fruquintinib
Fruquintinib is a highly selective and potent oral inhibitor of vascular endothelial factor receptor ("VEGFR") 1/2/3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity to minimize off-target toxicities, improve tolerability and provide more consistent target coverage. The generally good tolerability in patients to date, along with fruquintinib’s low potential for drug-drug interaction based on preclinical assessment, suggests that it may be highly suitable for combinations with other anti-cancer therapies.

About FRUTIGA in Gastric Cancer
FRUTIGA is a randomized, double-blind, Phase III trial evaluating the efficacy and safety of fruquintinib combined with paclitaxel for second-line treatment of advanced gastric or GEJ adenocarcinoma. The trial is designed to enroll patients who did not respond to first-line standard chemotherapy. Subjects will receive either fruquintinib combined with paclitaxel or placebo combined with paclitaxel. Patients will be randomized at a 1:1 ratio and stratified according to factors such as stomach vs. GEJ tumor type and performance status. The primary efficacy endpoint is overall survival. Secondary efficacy endpoints include progression-free survival (as defined by RECIST 1.1), objective response rate, disease control rate, duration of response, and quality-of-life score (EORTC QLQ-C30, version 3.0). Biomarkers related to the antitumor activity of fruquintinib will also be explored.

Additional details about this study can be found at clinicaltrials.gov, using identifier NCT03223376.

FRUTIGA was initiated following the results of an open label, multi-center Phase Ib dose finding/expansion study of fruquintinib in combination with paclitaxel (Taxol) as a second-line treatment in patients with advanced gastric cancer (clinicaltrials.gov identifier NCT02415023).

Other Fruquintinib Development
Fruquintinib was approved for marketing in China by the NMPA in September 2018 and commercially launched by Eli Lilly and Company ("Lilly") in late November 2018 under the brand name Elunate. Elunate is for the treatment of patients with metastatic colorectal cancer that have been previously treated with fluoropyrimidine, oxaliplatin and irinotecan, including those who have previously received anti-VEGF therapy and/or anti-EGFR therapy (RAS wild type). Results of the FRESCO study, a Phase III pivotal registration trial of fruquintinib in 416 patients with colorectal cancer ("CRC") in China, were published in The Journal of the American Medical Association, JAMA, in June 2018 (clinicaltrials.gov identifier: NCT02314819).

Chi-Med retains all rights to fruquintinib outside of China and is partnered with Lilly in China.

Global development of fruquintinib in CRC: We are initiating a Phase III registration study, known as the FRESCO-2 study, in the U.S., Europe and Japan in CRC. FRESCO-2 is expected to start enrolling patients in mid-2020. Based on our agreement with the U.S. Food and Drug Administration (FDA), the FRESCO and FRESCO-2 studies, if positive, could support our New Drug Application (NDA).

Immunotherapy combinations: We have entered into three collaboration agreements to evaluate the safety, tolerability and efficacy of fruquintinib in combination with programmed death-1 (PD-1) monoclonal antibodies, including with tislelizumab (BGB-A317), Tyvyt (sintilimab, IBI308) and geptanolimab (GB226, genolimzumab).

On June 4, 2020 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported that the European Commission (EC) has granted Janssen-Cilag International NV (Janssen) marketing authorization for the subcutaneous (SC) formulation of DARZALEX (daratumumab), for the treatment of adult patients with multiple myeloma in all currently approved DARZALEX intravenous (IV) formulation indications in frontline and relapsed / refractory settings (Press release, Halozyme, JUN 4, 2020, View Source [SID1234560834]). The approval follows a Positive Opinion by the CHMP of the European Medicines Agency (EMA) in April 2020. The SC formulation is administered as a fixed-dose over approximately three to five minutes, significantly less time than IV DARZALEX, which is given over several hours. Patients currently on IV DARZALEX will have the choice to switch to the SC formulation.

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"We are delighted that the subcutaneous formulation of DARZALEX has been granted marketing authorization in the EU with a broad label so soon after the CHMP positive opinion," said Dr. Helen Torley. "DARZALEX SC has the potential to improve the treatment experience for multiple myeloma patients and physicians in the European Union as patients may benefit from a shorter treatment time when compared with a multi-hour intravenous infusion."

The approval was based on data from two studies: the Phase III non-inferiority COLUMBA (MMY3012) study, which compared the SC formulation of daratumumab to the IV formulation in patients with relapsed or refractory multiple myeloma, and data from the Phase II PLEIADES (MMY2040) study, which evaluated SC daratumumab in combination with certain standard multiple myeloma regimens. The topline results from the COLUMBA study were announced in February 2019 and subsequently presented in oral sessions at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and the 24th European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress. Updated data of the COLUMBA and the PLEIADES studies were presented during poster sessions at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2019.

About ENHANZE Technology
Halozyme’s proprietary ENHANZE drug-delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.

On June 4, 2020 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported that it will present at the Goldman Sachs 41st Annual Global Healthcare Conference Webcast at 9:40 a.m. ET on Thursday, June 11, 2020 (Press release, Neurocrine Biosciences, JUN 4, 2020, View Source [SID1234560851]). Kevin Gorman, Chief Executive Officer, Eiry Roberts, Chief Medical Officer, and Kyle Gano, Chief Business Development and Strategy Officer, will present at the conference.

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The live presentation will be webcast and may be accessed on the Company’s website under Investors at www.neurocrine.com. A replay of the presentation will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.

On June 4, 2020 Rakuten Medical, Inc. (Rakuten Medical) and The University of Texas MD Anderson Cancer Center (MD Anderson) reported a strategic alliance collaboration agreement to advance the development of new cancer therapies based on Rakuten Medical’s proprietary Illuminox technology platform (Press release, Rakuten Medical, JUN 4, 2020, View Source [SID1234560819]).

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Under the terms of the agreement, Rakuten Medical and MD Anderson will collaborate to conduct studies based on the Illuminox technology platform and to determine study designs, combination therapies, and target patient populations for future clinical trials. The alliance is designed to expand development of the technology and bring a novel therapeutic approach to patients with cancer, with an initial focus on those with head and neck cancers. This agreement expands upon an existing sponsored research agreement between Rakuten Medical and MD Anderson.

"We are honored that MD Anderson has recognized the exciting potential of our Illuminox technology by entering into this strategic alliance agreement," said Hiroshi Mikitani, Chairman and CEO of Rakuten Medical. "We believe our collaboration will allow us to develop novel treatments for different cancer types. We are energized by MD Anderson’s shared optimism and conviction to bring treatments to patients in need."

The Illuminox technology platform is based on a cancer therapy called photoimmunotherapy, developed by Dr. Hisataka Kobayashi and colleagues from the National Cancer Institute. Illuminox is a technology combining drugs and laser device systems being evaluated for the treatment of different cancers.

"The Illuminox technology represents a new form of therapy with the potential to selectively target cancer cells while sparing surrounding normal tissues through light-activatable antibody-dye conjugates," said Jeffrey Myers, M.D., Ph.D., chair of Head and Neck Surgery at MD Anderson. "We are pleased to build upon our collaborative relationship with Rakuten Medical to work toward bringing investigational treatment options forward with the goal of providing the best options for our patients."

On June 4, 2020 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), reported a recap of a Key Opinion Leader (KOL) call sponsored by Canaccord Genuity and held on June 2, 2020 (Press release, Oncolytics Biotech, JUN 4, 2020, View Source [SID1234560835]). The call focused on recently announced clinical data from Oncolytics’ AWARE-1 study presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Breast Cancer Virtual Meeting 2020 and highlighted the ability of pelareorep to induce a pro-inflammatory tumor microenvironment across multiple breast cancer subtypes.

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Featured on the KOL call was Dr. Aleix Prat, M.D., Ph.D., Head of Medical Oncology at the Hospital Clínic of Barcelona, Associate Professor of the University of Barcelona, Head of the Translational Genomics and Targeted Therapeutics in Solid Tumors Group at August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Chair of SOLTI and lead translational investigator of the AWARE-1 study.

"I am highly encouraged by the recently announced AWARE-1 data, which demonstrate the potential of pelareorep to address pressing unmet needs in multiple breast cancer subtypes and treatment settings," said Dr. Prat. "Immunosuppressive tumor microenvironments are known to limit the efficacy of checkpoint inhibitor therapies and highlight the need for synergistic co-therapies to promote tumor inflammation. The data presented at the ESMO (Free ESMO Whitepaper) meeting show that pelareorep induces a rapid and persistent immune response and thus has the potential to address this critical need. Importantly, the data also validate T cell clonality as a biomarker of pelareorep response, which may ultimately accelerate pelareorep’s approval by facilitating the efficient design of pivotal studies."

The AWARE-1 study combines the appropriate intervention for each patient’s breast cancer sub-type, plus pelareorep, with or without atezolizumab (Tecentriq), followed by surgery in early-stage breast cancer patients. Patients are biopsied on day one (followed immediately by treatment), then again on day three, and for a final time three weeks post-treatment (just prior to mastectomy). Biomarker data from the paired patient biopsies are then collected and analyzed. At the time of data presentation at ESMO (Free ESMO Whitepaper) Breast Cancer, 13 patients had been enrolled in AWARE-1, and biopsy data were available on 6 of these.

Clinical findings highlighted during Dr. Prat’s discussion included:
•Intravenous administration of pelareorep led to robust, tumor-specific pelareorep replication.
•Pelareorep systemic administration increased tumor PD-L1 expression, infiltration of tumor immune lymphocytes, and CelTIL (a measurement of tumor-associated cellularity and tumor-infiltrating lymphocytes). These data demonstrate that pelareorep induces adaptive as well as innate immune responses and support the observed survival benefit in a previous randomized phase two study of pelareorep in metastatic breast cancer patients. Pelareorep-induced responses were both rapid (present three days after treatment) and persistent (remained through day twenty-one).

•Pelareorep-induced increase in tumor PD-L1 expression demonstrates the synergistic potential between pelareorep and checkpoint inhibitor therapies. Many patients are ineligible for (and fail to respond to) checkpoint inhibitor-based therapies due to an immunosuppressive tumor microenvironment and low PD-L1 expression.
•AWARE-1 data further support T cell clonality as a biomarker of pelareorep response. Peripheral T cell clonality correlated with changes in the tumor microenvironment as well as CelTIL, which is associated with favorable clinical response. These data highlight T cell clonality’s potential as a biomarker of pelareorep response and are consistent with data from a prior clinical study of pelareorep in pancreatic cancer. Use of T cell clonality as a predictive biomarker may facilitate the design of registrational trials and improve chances of trial success across multiple indications.
•Data suggest that pelareorep treatment has multiple therapeutic mechanisms in cancer. These mechanisms include the induction of an adaptive immune response, direct tumor cell killing, and induction of a durable immune memory effect against cancer cells. The multiple mechanisms of pelareorep may expand its clinical opportunity across multiple breast cancer subtypes (e.g. triple negative and HR+/HER2- breast cancer) and treatment settings (e.g. as an anti-PD-L1 co-therapy or neoadjuvant treatment).

Oncolytics would like to thank Dr. Prat for his time and insightful commentary, as well as Canaccord Genuity for hosting the call. A replay of the call can be found on the company website at View Source

About Breast Cancer
Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25 percent of all cancers in women. Incidence rates vary widely across the world, from 27 per 100,000 in Middle Africa and Eastern Asia to 85 per 100,000 in Northern America. It is the fifth most common cause of death from cancer in women globally, with an estimated 522,000 deaths.

Breast cancer starts when cells in the breast begin to grow out of control. These cells usually form a tumor that can often be seen on an x-ray or felt as a lump. The malignant tumor (cancer) is getting worse when the cells grow into (invade) surrounding tissues or spread (metastasize) to distant areas of the body.

About AWARE-1
AWARE-1 is an open label window-of-opportunity study in early-stage breast cancer enrolling 38 patients into five cohorts:

•Cohort 1 (n=10), HR+ / HER2- (pelareorep + letrozole)
•Cohort 2 (n=10), HR+ / HER2- (pelareorep + letrozole + atezolizumab)
•Cohort 3 (n=6), TNBC (pelareorep + atezolizumab)
•Cohort 4 (n=6), HR+ / HER2+ (pelareorep + trastuzumab + atezolizumab)
•Cohort 5 (n=6), HR- / HER2+ (pelareorep + trastuzumab + atezolizumab)

The study combines pelareorep with the standard of care according to breast cancer subtype and atezolizumab. Patients are biopsied on day one followed immediately by treatment, then again on day three, and a final biopsy after three weeks, on the day of their mastectomy. Data generated from this study is intended to confirm that the virus is acting as a novel immunotherapy and to provide comprehensive

biomarker data by breast cancer subtype. The primary endpoint of the study is overall CelTIL (a measurement of cellularity and tumor-infiltrating lymphocytes). Secondary endpoints for the study include CelTIL by breast cancer subtype, safety and tumor, and blood-based biomarkers.

About Pelareorep
Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.